The Food and Drug Administration (FDA) is issuing this draft guidance to describe the Agency’s policy for notifying the public about medical device “emerging signals.” For the purposes of this guidance, an emerging signal is new information about a medical device used in clinical practice…
FDA likely to require substantial clinical data for interchangeable biosimilars, lawyers say
The U.S. Food and Drug Administration is “almost certain) to require clinical data in order for companies to demonstrate interchangeability between a biosimilar and its reference product, thought the question of how much data will be required is major factor in determining how quickly the U.S. biosimilars market will take off, according to a new report from the law firm Goodwin Proctor.
Mobile health: the power of wearables, sensors, and apps to transform clinical trials
Google-backed gene editing startup files for $100M IPO
Editas Medicine filed paperwork this morning for a $100 million initial public offering (IPO). The Cambridge, Massachusetts-based startup would become the first publicly-traded company specializing in gene editing, according to Bloomberg Business.
2015 a year in review: the year of clinical trial innovation
www.appliedclinicaltrialsonline.com
The clinical trials industry has undergone quite a bit of change in 2015, and may arguably be deemed the year of the ramping of clinical trial innovation.
Revolutionary neuroscience technique slated for human clinical trials
A technique called optogenetics has transformed neuroscience during the past 10 years by allowing researchers to turn specific neurons on and off in experimental animals.
Personalised tissue will change drug development, says researcher
A recently developed stem cell programming technique could produce human tissue on-demand for testing new drug treatments.
We need clinical trials but we must remain vigilant against their abuse
Startling new research has revealed that three-quarters of healthy participants in clinical trials conceal some health information to avoid exclusion. This could have wide-reaching consequences for all of us.
Why CRISPR-Cas 9 is being hailed as the scientific “Breakthrough of the Year”
CRISPR is having a moment.
This week the gene editing system was declared the “Breakthrough of the Year” by editors of the journal Science. A day earlier, Nature named the Chinese researcher Junjiu Huang one of the 10 people who mattered in 2015 for being the first to use the CRISPR system to edit the DNA of human embryos (albeit ones that weren’t viable).
Fitbit’s heart rate monitoring accuracy questioned in class action suit
Fitbit is facing yet another class action suit, this time over its heart rate monitoring, which plaintiffs claim is inaccurate to a dangerous degree.
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